A Phase 2 interventional study of BMS-986511 and Placebo in Major Depressive Disorder, sponsored by Bristol-Myers Squibb. Not yet recruiting at 27 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 200 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BMS-986511
Drug: BMS-986511
Drug: Placebo
Specified dose on specified days
Also known as: Evifacotrep
Specified dose on specified days
Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score
Time frame: Up to Day 57
Number of Participants with Treatment Emergent Adverse Events (AEs)
Time frame: Up to 71 days
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 71 days
Number of Participants with AEs Leading to Treatment Discontinuation
Time frame: Up to 71 days
Number of Participants with AEs Leading to Death
Time frame: Up to Day 71
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Start is estimated for Oct 2026; primary completion for Nov 2028, 24 months later.
Of 96 industry-sponsored phase 2 interventional studies under Depressive Disorder, Major, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's planned 24 months is above that.
Counting every sponsor, half of 195 studies reached it within 22 months; a quarter within 14 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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